Anhedonia in Healthy VolunteersNCT03545399
The Effect of an Edible Algal Extract (Ulva Lactuca) on the Component of Depression in Healthy Volunteers With Anhedonia
A study testing Ulva Lactuca in people with Anhedonia in Healthy Volunteers, run by CEN Biotech.
Trial summary
The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anhedonia in Healthy Volunteers
- What is being tested?
- Ulva Lactuca
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 29 Jun 2015to 31 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged between 18 and 65 years
- Presenting a anhedonia with a score ≥5 on the SHAPS Scale
- Declaring feeling low for at least 4 weeks characterised by a component of depression evaluated on the QIDS-SR
- Being able to apprehend and fill in the evaluation scales
Who cannot join
- Subject with a major depressive episode as per the DSM V scale, with a HAM D > 8, already on anxiolytic, antidepressor, neuroleptic or any other medicinal treatment liable to influence mood (e.g. benzodiazepines) in the last 30 days or using illegal psychotropic substances, or a with daily alcohol intake of more than three glasses of wine
- Presenting a psychiatric disorder or in state of post-traumatic stress or having had an electroconvulsive therapy in the last 6 months
- Female subject pregnant or breast-feeding or of childbearing age and not using effective means of contraception
- subject suffering from an allergy or intolerance to seafood products (fish, shellfish and seaweed)
About this study
Official title: Essai Clinique randomisé en Double Aveugle Contre Placebo de l'évaluation de l'Effet d'un Extrait d'Algues Comestibles (Ulva Lactuca) Chez Des Volontaires Sains présentant Une anhédonie associée à Une Baisse de Moral
The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.L extract in healthy volunteers whose anhedonia was characterized by a component of depression.
Read the detailed description
The trial comprised three visits: a medical enrollment visit on D0, an intermediate visit on D28 and a final visit on D84. A psychologist made a telephone call after 7 days to check there was no sudden change in the subject's depressive state. During the visits, the subject was examined by a doctor and the psychometric tests were administered by a psychologist. Outside the visits, the subject was monitored by a self-reporting questionnaire in the manner described below.
After obtaining informed written consent and validating the inclusion and exclusion criteria, notably the absence of MDE as per DSM V, the investigator enrolled the subject in the trial. The physician described the subject's demographic and general clinical characteristics, the main medical and surgical history and any current treatment if those pathologies were still present, and any previous antidepressant, anxiolytic or neuroleptic treatments. The doctor asked the subject to complete the SHAPS and QIDS -SR questionnaires and item 7 of the HAM-D. The doctor then handed the subject self-evaluation questionnaires explaining how to complete them and the dates at which they were to be completed. The physician gave the patient a batch of the placebo or a batch of Ulva lactuca as per the randomization. The doctor told the subject a psychologist would be in touch after one week by telephone to check no DSM V severity criterion had arisen.
The investigating doctor saw the subject again at the four-week intermediate visit and at the final visit at the end of the 12th week of follow-up. The doctor collected the self-questionnaires at these visits and the same items as at the enrollment visit were recorded by the physician for describing how the items had evolved and notably the SHAP scale score, the QIDS-SR and item 7 of the HAM-D. In addition, the physician recorded the subject's satisfaction with the treatment evaluated on the PGII (Patient Global Improvement Impression), reported any undesirable affects and gave his/her own opinion on the efficacy of treatment using the Clinical Global Improvement Impression (CGII).
- Conditions
- Anhedonia in Healthy Volunteers
- Being tested
- Ulva Lactuca, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulva LactucaDietary supplement
The dose was taken with a glass of water during the evening meal once daily
PlaceboDietary supplement
The dose was taken with a glass of water during the evening meal once daily
| Study group | Role | What they receive |
|---|---|---|
| Ulva Lactuca | Experimental | The subject is given a capsule containing a concentrated fraction of freeze-dried and crushed hydrosoluble extract of seaweeds. The dose tested of extract of seaweeds is of 6.45mg per kg weight. The daily dose is 3 capsules per day for subjects weighing between 50 and 70kg, 4 capsules per day for subjects weighing between 70 and 90kg and 5 capsules per day for subjects weighing between 90 and 110kg. The duration of the treatment is 12 weeks. Receives: Dietary Supplement: Ulva Lactuca |
| Placebo | Placebo comparator | The subject is given a capsule looking alike that of the active product but containing no extract of seaweeds.The duration of the treatment is 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of anhedonia in healthy subjects
The evolution of anhedonia in healthy subjects whose anhedonia was characterized by a component of depression was measured by the Snaith-Hamilton Pleasure Scale (SHAPS).The SHAPS questionnaire is composed of 14 questions, the total score of the SHAPS varies between 0 and 14. Severe anhedonia will be observed if the SHAPS score is strictly greater than 5.
Measured: 84 days
Secondary outcomes (6)
Evolution of the subject's mood
Evolution of the mood of subjects measured by the Brief Mood Introspection Scale (BMIS).Each "positive" item (Dynamic, Happy, Compassionate, Content, Energetic, Quiet, Affectionate and Vivid) is rated from 1 "Not at all" to 4 "Absolutely". Each item "negative" (Sad, Tired, Melancholic, Excited, Exhausted, Grumpy, Nervous and Annoyed) is inversely rated from 1 "quite" to 4 "not at all". The BMIS questionnaire is composed of 16 questions, and will be calculated by adding the answers of these 16 items. The BMIS score varies between 16 and 64.
Measured: 84 days
The effect on work and other activities
The effect on work and other activities according to item 7 of the Hamilton Rating Scale for Depression (HAM-D).The HAM-D is a scale for depression composed of 17 questions and varies between 0 and 58.
The HAM-D score will also be classified into 5 classes according to the following model:
0-7 None; 8-13 Light; 14-18 Moderate; 19-22 Severe; > 23 Very severe
Measured: 84 days
Evolution of the components of depression
Evolution of the components of depression is measured by the Quick Inventory of Depressive Symptomatology -Self-Report (QIDS-SR).QIDS-SR questionnaire is composed of 16 questions. Each answer is scored from 0 to 3. The symptomatology is more important with a higher score. The total score fluctuates between 0 and 27.
The QIDS score will also be classified into 5 classes according to the following model:
0-5 None; 6-10 Lightweight; 11-15 Moderate; 16-20 Severe; > 20 Very severe
Measured: 84 days
Evaluation of subject's satisfaction
Subject's satisfaction with the treatment was evaluated by the Patient Global Improvement Impression (PGII)
Measured: 84 days
Evaluation of product's tolerance
The evaluation of product's tolerance for the whole period of the trial is done by the reporting of Serious Adverse Event if any
Measured: 84 days
Evaluation of the investigator's opinion
Evaluation of the investigator's opinion is measured by the Clinical Global Improvement Impression (CGII)
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start29 Jun 2015
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anhedonia in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre double-blind randomized placebo-controlled clinical trial on parallel arms of two groups of 45 subjects
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Nutriment, Biovet Conseil, Amadeite SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545399
- Sponsor's protocol ID
- C1365
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allaert FA, Demais H, Collen PN. A randomized controlled double-blind clinical trial comparing versus placebo the effect of an edible algal extract (Ulva Lactuca) on the component of depression in healthy volunteers with anhedonia. BMC Psychiatry. 2018 Jun 28;18(1):215. doi: 10.1186/s12888-018-1784-x.
PubMed 29954354
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essai Clinique randomisé en Double Aveugle Contre Placebo de l'évaluation de l'Effet d'un Extrait d'Algues Comestibles (Ulva Lactuca) Chez Des Volontaires Sains présentant Une anhédonie associée à Une Baisse de Moral
- ClinicalTrials.gov ID
- NCT03545399
- Acronym / sponsor ID
- C1365
- Conditions
- Anhedonia in Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- CEN Nutriment, Biovet Conseil, Amadeite SAS
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.L extract in healthy volunteers whose anhedonia was characterized by a component of depression.
Detailed description
The trial comprised three visits: a medical enrollment visit on D0, an intermediate visit on D28 and a final visit on D84. A psychologist made a telephone call after 7 days to check there was no sudden change in the subject's depressive state. During the visits, the subject was examined by a doctor and the psychometric tests were administered by a psychologist. Outside the visits, the subject was monitored by a self-reporting questionnaire in the manner described below.
After obtaining informed written consent and validating the inclusion and exclusion criteria, notably the absence of MDE as per DSM V, the investigator enrolled the subject in the trial. The physician described the subject's demographic and general clinical characteristics, the main medical and surgical history and any current treatment if those pathologies were still present, and any previous antidepressant, anxiolytic or neuroleptic treatments. The doctor asked the subject to complete the SHAPS and QIDS -SR questionnaires and item 7 of the HAM-D. The doctor then handed the subject self-evaluation questionnaires explaining how to complete them and the dates at which they were to be completed. The physician gave the patient a batch of the placebo or a batch of Ulva lactuca as per the randomization. The doctor told the subject a psychologist would be in touch after one week by telephone to check no DSM V severity criterion had arisen.
The investigating doctor saw the subject again at the four-week intermediate visit and at the final visit at the end of the 12th week of follow-up. The doctor collected the self-questionnaires at these visits and the same items as at the enrollment visit were recorded by the physician for describing how the items had evolved and notably the SHAP scale score, the QIDS-SR and item 7 of the HAM-D. In addition, the physician recorded the subject's satisfaction with the treatment evaluated on the PGII (Patient Global Improvement Impression), reported any undesirable affects and gave his/her own opinion on the efficacy of treatment using the Clinical Global Improvement Impression (CGII).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre double-blind randomized placebo-controlled clinical trial on parallel arms of two groups of 45 subjects
| Arm | Type | Receives |
|---|---|---|
| Ulva Lactuca | Experimental | Dietary Supplement: Ulva LactucaThe subject is given a capsule containing a concentrated fraction of freeze-dried and crushed hydrosoluble extract of seaweeds. The dose tested of extract of seaweeds is of 6.45mg per kg weight. The daily dose is 3 capsules per day for subjects weighing between 50 and 70kg, 4 capsules per day for subjects weighing between 70 and 90kg and 5 capsules per day for subjects weighing between 90 and 110kg. The duration of the treatment is 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe subject is given a capsule looking alike that of the active product but containing no extract of seaweeds.The duration of the treatment is 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women aged between 18 and 65 years
- Presenting a anhedonia with a score ≥5 on the SHAPS Scale
- Declaring feeling low for at least 4 weeks characterised by a component of depression evaluated on the QIDS-SR
- Being able to apprehend and fill in the evaluation scales
Key exclusion criteria (4 listed)
- Subject with a major depressive episode as per the DSM V scale, with a HAM D > 8, already on anxiolytic, antidepressor, neuroleptic or any other medicinal treatment liable to influence mood (e.g. benzodiazepines) in the last 30 days or using illegal psychotropic substances, or a with daily alcohol intake of more than three glasses of wine
- Presenting a psychiatric disorder or in state of post-traumatic stress or having had an electroconvulsive therapy in the last 6 months
- Female subject pregnant or breast-feeding or of childbearing age and not using effective means of contraception
- subject suffering from an allergy or intolerance to seafood products (fish, shellfish and seaweed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulva LactucaThe dose was taken with a glass of water during the evening meal once daily | Dietary supplement | Ulva Lactuca |
| PlaceboThe dose was taken with a glass of water during the evening meal once daily | Dietary supplement | Placebo |
Primary outcome
Evolution of anhedonia in healthy subjects
Time frame: 84 days
The evolution of anhedonia in healthy subjects whose anhedonia was characterized by a component of depression was measured by the Snaith-Hamilton Pleasure Scale (SHAPS).The SHAPS questionnaire is composed of 14 questions, the total score of the SHAPS varies between 0 and 14. Severe anhedonia will be observed if the SHAPS score is strictly greater than 5.
6 secondary outcomes
Evolution of the subject's mood
Time frame: 84 days
The effect on work and other activities
Time frame: 84 days
Evolution of the components of depression
Time frame: 84 days
Evaluation of subject's satisfaction
Time frame: 84 days
Evaluation of product's tolerance
Time frame: 84 days
Evaluation of the investigator's opinion
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Derived from this study: PubMed 29954354Allaert FA, Demais H, Collen PN. A randomized controlled double-blind clinical trial comparing versus placebo the effect of an edible algal extract (Ulva Lactuca) on the component of depression in healthy volunteers with anhedonia. BMC Psychiatry. 2018 Jun 28;18(1):215. doi: 10.1186/s12888-018-1784-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ulva Lactuca in people with Anhedonia in Healthy Volunteers, run by CEN Biotech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of anhedonia in healthy subjects (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.